Methods for delivering a drug to a hospital patient for short-term use while minimizing long-term use of the drug

Abstract

Novel methods for delivering a drug to hospital patients for short-term in-hospital use while minimizing long-term use of the drug. Embodiments are provided in which hospitals are identified which may be eligible to treat patients, for example, perform certain types of surgery, and which have measures in place to limit use of the drug to short-term use. The identified hospitals are preferably registered in a storage medium, including computer readable storage media, and may be authorized to receive the shipments of the drug. The received drug may then be dispensed to the patient.

1 - 8 . (canceled) 
     
     
         9 . A method of treating a patient, the method comprising intravenously administering to the patient a composition comprising a therapeutically effective amount of alvimopan less than one day prior to surgery followed by administering the alvimopan composition to the patient twice daily beginning the day after surgery, wherein the method is carried out in a hospital that has acknowledged that: (i) hospital staff who prescribe, dispense or administer the alvimopan composition have been provided education materials on the need to limit the use of the alvimopan composition to short-term, inpatient use; (ii) the patient will not receive more than 15 total doses of the alvimopan composition; and (iii) the alvimopan composition will not be dispensed to the patient after being discharged from the hospital. 
     
     
         10 . The method of  claim 9 , wherein the amount of the alvimopan administered intravenously after surgery is in from about 0.1 mg to about 6 mg. 
     
     
         11 . The method of  claim 9 , wherein the amount of the alvimopan administered intravenously after surgery is in from about 1 mg to about 3 mg. 
     
     
         12 . A method of treating a patient, the method comprising administering to the patient a composition comprising a therapeutically effective amount of alvimopan less than one day prior to surgery followed by administering the alvimopan composition twice daily after surgery, wherein the method is carried out in a hospital that has acknowledged that: (i) hospital staff who prescribe, dispense or administer the alvimopan composition have been provided education materials on the need to limit the use of the alvimopan composition to short-term, inpatient use; (ii) the patient will not receive more than 15 total doses of the alvimopan composition; and (iii) the alvimopan composition will not be dispensed to the patient after being discharged from the hospital. 
     
     
         13 . The method of  claim 12 , wherein the alvimopan is administered orally. 
     
     
         14 . The method of  claim 13 , wherein the composition comprises about 12 mg of alvimopan. 
     
     
         15 . The method of  claim 14 , wherein the composition is administered in hot-melt gelatin capsule, wherein the alvimopan is suspended in polyethylene glycol. 
     
     
         16 . The method of  claim 12 , wherein the alvimopan is administered intravenously. 
     
     
         17 . The method of  claim 16 , wherein the amount of the alvimopan administered intravenously after surgery is in from about 0.1 mg to about 6 mg. 
     
     
         18 . The method of  claim 16 , wherein the amount of the alvimopan administered intravenously after surgery is in from about 1 mg to about 3 mg. 
     
     
         19 . A method for delivering alvimopan to hospital patients for short-term use while minimizing ischemic cardiovascular events associated with alvimopan administration, comprising:
 (a) identifying hospitals that may be eligible to dispense the alvimopan, said eligibility requiring that said hospitals perform surgery or are acute care hospitals and treat patients who are inpatients;   (b) providing said identified hospitals with literature regarding use of the alvimopan including dosing recommendations and contraindications, and which describes the observation of an adverse event associated with long-term use of the drug;   (c) identifying a subpopulation of said identified hospitals which treat the patients and which have measures in place to limit use of the alvimopan to short-term use;   (d) authorizing said subpopulation to receive shipment of the alvimopan; and   (e) dispensing the alvimopan to the patients in said subpopulation for short-term use;   
       wherein the patients are hospital inpatients and the delivery is limited to in-hospital administration. 
     
     
         20 . The method of  claim 19 , wherein short-term use comprises no more than 15 doses of alvimopan. 
     
     
         21 . The method of  claim 19 , wherein short-term use comprises 15 doses of alvimopan. 
     
     
         22 . The method of  claim 19 , wherein the alvimopan is administered orally. 
     
     
         23 . The method of  claim 19 , wherein the alvimopan is administered intravenously. 
     
     
         24 . The method of  claim 19 , wherein the ischemic cardiovascular event is myocardial infarction. 
     
     
         25 . A method of treating a patient undergoing abdominal surgery while reducing the risk of myocardial infarction, said method comprising administering a composition comprising a therapeutically effective amount of alvimopan to the patient, wherein said patient is in a hospital that has measures in place to limit use of the alvimopan to no more than 15 total doses. 
     
     
         26 . The method of  claim 25 , wherein the hospital has acknowledged that hospital staff who prescribe, dispense or administer the alvimopan composition have been provided education materials on the need to limit the use of the alvimopan composition to short-term, inpatient use. 
     
     
         27 . The method of  claim 25 , wherein the alvimopan is administered orally. 
     
     
         28 . The method of  claim 25 , wherein the alvimopan is administered intravenously. 
     
     
         29 . The method of  claim 25 , wherein the patient receives no more than 15 total doses of alvimopan.